Prospective, open-label, interventional study to explore the efficacy of the ghrelin agonist anamorelin in patients with cachexia associated with chronic obstructive pulmonary disease

Ikari Jun0 sites28 target enrollmentNovember 13, 2023

Overview

No summary available.

Registry

who.int

Start Date

November 13, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Ikari Jun

•1\) Adults 18years of age or older at the time of consent
•2\) Patients diagnosed with COPD
•3\) Patients with non\-arbitrary wight loss of 2% or more within 3\-6 months, or BMI\<21kg/m2
•4\) Patients who meet one or more criterias of following three
•a. Anorexia
•b. Decreased grip strength (\<28kg in men and \<18kg in women)
•c. CRP \> 0\.5mg/dL
•5\) Patients receiving appropriate pharmacological therapy for COPD
•6\) Patients who have been informed of the study and who have given written consent of their own free will

•1\) Patients who have been introduced to new inhalation or nutritional therapy during the period from 4 weeks prior to the start of the study to the start of the study
•2\) Poorly controlled diabetes mellitus
•3\) Patients with the following contraindications to anamorelin administration
•a. Patients with a history of hypersensitivity to anamorelin
•b. Patients with congestive heart failure
•c. Patients with myocardial infarction or angina pectoris
•d. Patients with severe conduction defects (e.g., complete atrioventricular block)
•e. Patients receiving the following drugs (clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, telaprevir, voriconazole, ritonavir\-containing products, cobicistat\-containing products)
•f. Hepatic dysfunction of moderate severity or greater (Child\-Pugh Classification B or C)
•g. Patients with difficulty in oral intake of food due to gastrointestinal obstruction or other organic abnormalities of the gastrointestinal tract.